OSANCT05060133
Changes of the Upper Airway Volume After Orthognathic Surgery
An observational study of OSA and Malocclusion, run by Lund University Hospital at 1 site in Sweden.
Trial summary
The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume. The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- OSA, Malocclusion, Dentofacial Deformities
- What is being tested?
- Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2021to 28 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Consecutive patients, aged between 18 to 30 years, with diagnosed maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspects from normal occlusion
Who may be able to join
- Maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspect from normal occlusion measured as interincisal distance
- Age between 18 to 30 years
Who cannot join
- Systemic diseases in the musculoskeletal apparatus
- Drug abuse
- Poor psychic status
- Disease in the temporomandibular joint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of the Upper Airway Volume After Orthognathic Surgery - is This a Treatment Option of Severe Obstructive Sleep Apnea?
The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume.
The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements.
Secondary objectives are the analysis of any correlation between the magnitude of the movement and the airway volume, correlation between the direction of the movements and the changes in airway volume and correlation with Health-Related Quality of Life (HRQoL). Expected confounding factors like smoking habits and Body Mass Index (BMI) will be analyzed.
Read the detailed description
Background Orthognathic surgery affects the position of the teeth and jaws. The upper airway compartment is in close approximation to these tissues. Consequently, changes of the respiratory volume after surgical treatment in this region is expected.
Orthognathic surgery The correction of severe malocclusions and dentofacial deformities has since the beginning of 20th century been treated with orthodontic and surgical methods. Epidemiologic surveys reveal that about 5 % of the western population has dentofacial disproportions of a magnitude that affect both function and facial aesthetics.
Respiratory disability Obstructive sleep apnea, estimated to occur in between 5% and 10% of the western countries' population. Disabilities in the upper airway may affect the patient's general health and quality of life. Breathing incapability often lead to impaired sleep and consequently decrease the individual's overall capacity and performance. Known predisposing factors are obesity, smoking and age.
Treatment of respiratory disabilities Medical, behavioral and surgical treatment options are prospected methods and the treatment is individually planned in detail. The complex nature of obstructive sleep apnea may require multidisciplinary assessment.
Orthognathic surgery as treatment for obstructive sleep apnea syndrome (OSAS) Correction of anatomical abnormalities may cure obstructive sleep apnea or improve compliance with positive airway pressure treatment. Orthognathic surgery with an anterior movement of the jaws can increase the airway volume and facilitate breathing.
Measurements and evaluation of the upper airway volume Different methods of measuring the upper airway, like physio metric and radiological are present.
Project plan Subjects The study is performed retrospectively on a prospective material. Sixty-two consecutive patients aged between 18 to 30 years with Angle class III occlusion were included in the study.
Patients with systemic diseases in the musculoskeletal apparatus, drug abuse, poor psychic status or disease in the temporomandibular joint were excluded from the study.
Methods The study is performed retrospectively on a prospective material. Examination with clinical examination, BMI, HRQoL questionnaire, dental casts, photography and two- and three-dimensional radiographs and cephalometric measures was performed prior to surgery.
The patient's data (x-ray and photographs) were linked together in computer software programs and used for cephalometric analysis and simulation of the orthodontic and surgical movements (Fasad® and Simplant® PRO 12.00 OMS). The treatment was performed in accordance with this plan.
The last follow up was performed 12 months after surgery including identical registrations as prior to surgery, described above. HRQoL questionnaires consisted of Oral Health Impact Profile (OHIP-S), Jaw Functional Limitation Scale (JFLS-20) and Orofacial Aesthetic Scale (OAS-S). The results from the presurgical questionnaire will be compared with the postsurgical results. Twenty subjects were asked to fill in the follow-up questionnaire twice with two weeks interval for a reliability test of the method.
The pre- and postoperative CT will be compared in a software for measurements of upper airway volume with the software Philips IntelliSpace® Portal, version 11. Measures will be performed with an divided analysis of the upper airway according to the method described by Kim. Thus, the upper airway segmented into four compartments. The measurements will be performed on the sole segment volume and the total airway volume. A comparison of jaw movements, changes in airway volume, BMI and HRQoL will be performed.
Statistical methods The sample size, 62 patients, was based on numbers included in previous similar studies from other centers.
Simple statistics, mean and standard deviation (SD), for all variables will be used. Differences in airway volume and movements, preoperatively and postoperatively will be compared with McNemar's-test. Wilcoxon's paired-sample test will be used for analyzing airway volume before and after surgery as a numeric variable. The reliability test, performed as a test-retest, will be analyzed with the intraclass correlation coefficient, Fisher's test for pair comparisons and Pearson's correlation coefficient. Mann-Whitney-test will be performed to detect differences between questionnaire responses and clinical findings, i.e. BMI, and volumetric findings. The data will be assessed by using Spearman correlation analysis and simple linear regression analysis. Two-sided tests and alpha level 0.05 will be used. Confidence interval (CI) will be calculated. For all computations IBM® SPSS® statistical software will be used.
- Conditions
- OSA, Malocclusion, Dentofacial Deformities
- Being tested
- Orthognathic Surgery
- Medical subject headings
- Malocclusion, Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic SurgeryProcedure or surgery
Surgical corrections of dentofacial deformities and malocclusions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in upper airway volume
Measurements in three dimensional radiographs from pre- and postoperative recordings.
Measured: Preoperative and 12 months postoperative follow up.
Secondary outcomes (2)
Correlation BMI and upper airway volume.
Correlation between changes in Upper airway volume and Body mass index (BMI).
Measured: Preoperative and 12 months postoperative follow up.
Direction of surgical movements
Correlation between the direction of the surgical movements and the changes of the upper airway volume.
Measured: Preoperative and 12 months postoperative follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start15 May 2021
- Primary completion31 Aug 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Bengtsson, Lund University Hospital
- Investigators
- Martin Bengtsson, DDS, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060133
- Sponsor's protocol ID
- OFRS939554
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Walsleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep. 2001 Feb 1;24(1):96-105. doi: 10.1093/sleep/24.1.96.
PubMed 11204058Moscarino S, Kotter F, Brandt M, Modabber A, Kniha K, Holzle F, Wolf M, Mohlhenrich SC. Influence of different surgical concepts for moderate skeletal class II and III treatment on the nasopharyngeal airway space. J Craniomaxillofac Surg. 2019 Oct;47(10):1489-1497. doi: 10.1016/j.jcms.2019.07.006. Epub 2019 Jul 18.
PubMed 31399294Kim JS, Kim JK, Hong SC, Cho JH. Pharyngeal airway changes after sagittal split ramus osteotomy of the mandible: a comparison between genders. J Oral Maxillofac Surg. 2010 Aug;68(8):1802-6. doi: 10.1016/j.joms.2009.11.010. Epub 2010 May 26.
PubMed 20537778Kim YJ, Hong JS, Hwang YI, Park YH. Three-dimensional analysis of pharyngeal airway in preadolescent children with different anteroposterior skeletal patterns. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):306.e1-11; discussion 306-7. doi: 10.1016/j.ajodo.2009.10.025.
PubMed 20197163Bengtsson M, Wall G, Greiff L, Rasmusson L. Treatment outcome in orthognathic surgery-A prospective randomized blinded case-controlled comparison of planning accuracy in computer-assisted two- and three-dimensional planning techniques (part II). J Craniomaxillofac Surg. 2017 Sep;45(9):1419-1424. doi: 10.1016/j.jcms.2017.07.001. Epub 2017 Jul 12.
PubMed 28800842Bengtsson M, Wall G, Miranda-Burgos P, Rasmusson L. Treatment outcome in orthognathic surgery - A prospective comparison of accuracy in computer assisted two and three-dimensional prediction techniques. J Craniomaxillofac Surg. 2018 Nov;46(11):1867-1874. doi: 10.1016/j.jcms.2017.01.035. Epub 2017 Feb 13.
PubMed 28318923Pellby D, Bengtsson M. Do Patients Detect Changes in Breathing After Orthognathic Surgery? J Oral Maxillofac Surg. 2024 Jan;82(1):36-46. doi: 10.1016/j.joms.2023.09.017. Epub 2023 Sep 27.
PubMed 37858599
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of the Upper Airway Volume After Orthognathic Surgery - is This a Treatment Option of Severe Obstructive Sleep Apnea?
- ClinicalTrials.gov ID
- NCT05060133
- Acronym / sponsor ID
- OFRS939554
- Conditions
- OSA, Malocclusion, Dentofacial Deformities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume.
The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements.
Secondary objectives are the analysis of any correlation between the magnitude of the movement and the airway volume, correlation between the direction of the movements and the changes in airway volume and correlation with Health-Related Quality of Life (HRQoL). Expected confounding factors like smoking habits and Body Mass Index (BMI) will be analyzed.
Detailed description
Background Orthognathic surgery affects the position of the teeth and jaws. The upper airway compartment is in close approximation to these tissues. Consequently, changes of the respiratory volume after surgical treatment in this region is expected.
Orthognathic surgery The correction of severe malocclusions and dentofacial deformities has since the beginning of 20th century been treated with orthodontic and surgical methods. Epidemiologic surveys reveal that about 5 % of the western population has dentofacial disproportions of a magnitude that affect both function and facial aesthetics.
Respiratory disability Obstructive sleep apnea, estimated to occur in between 5% and 10% of the western countries' population. Disabilities in the upper airway may affect the patient's general health and quality of life. Breathing incapability often lead to impaired sleep and consequently decrease the individual's overall capacity and performance. Known predisposing factors are obesity, smoking and age.
Treatment of respiratory disabilities Medical, behavioral and surgical treatment options are prospected methods and the treatment is individually planned in detail. The complex nature of obstructive sleep apnea may require multidisciplinary assessment.
Orthognathic surgery as treatment for obstructive sleep apnea syndrome (OSAS) Correction of anatomical abnormalities may cure obstructive sleep apnea or improve compliance with positive airway pressure treatment. Orthognathic surgery with an anterior movement of the jaws can increase the airway volume and facilitate breathing.
Measurements and evaluation of the upper airway volume Different methods of measuring the upper airway, like physio metric and radiological are present.
Project plan Subjects The study is performed retrospectively on a prospective material. Sixty-two consecutive patients aged between 18 to 30 years with Angle class III occlusion were included in the study.
Patients with systemic diseases in the musculoskeletal apparatus, drug abuse, poor psychic status or disease in the temporomandibular joint were excluded from the study.
Methods The study is performed retrospectively on a prospective material. Examination with clinical examination, BMI, HRQoL questionnaire, dental casts, photography and two- and three-dimensional radiographs and cephalometric measures was performed prior to surgery.
The patient's data (x-ray and photographs) were linked together in computer software programs and used for cephalometric analysis and simulation of the orthodontic and surgical movements (Fasad® and Simplant® PRO 12.00 OMS). The treatment was performed in accordance with this plan.
The last follow up was performed 12 months after surgery including identical registrations as prior to surgery, described above. HRQoL questionnaires consisted of Oral Health Impact Profile (OHIP-S), Jaw Functional Limitation Scale (JFLS-20) and Orofacial Aesthetic Scale (OAS-S). The results from the presurgical questionnaire will be compared with the postsurgical results. Twenty subjects were asked to fill in the follow-up questionnaire twice with two weeks interval for a reliability test of the method.
The pre- and postoperative CT will be compared in a software for measurements of upper airway volume with the software Philips IntelliSpace® Portal, version 11. Measures will be performed with an divided analysis of the upper airway according to the method described by Kim. Thus, the upper airway segmented into four compartments. The measurements will be performed on the sole segment volume and the total airway volume. A comparison of jaw movements, changes in airway volume, BMI and HRQoL will be performed.
Statistical methods The sample size, 62 patients, was based on numbers included in previous similar studies from other centers.
Simple statistics, mean and standard deviation (SD), for all variables will be used. Differences in airway volume and movements, preoperatively and postoperatively will be compared with McNemar's-test. Wilcoxon's paired-sample test will be used for analyzing airway volume before and after surgery as a numeric variable. The reliability test, performed as a test-retest, will be analyzed with the intraclass correlation coefficient, Fisher's test for pair comparisons and Pearson's correlation coefficient. Mann-Whitney-test will be performed to detect differences between questionnaire responses and clinical findings, i.e. BMI, and volumetric findings. The data will be assessed by using Spearman correlation analysis and simple linear regression analysis. Two-sided tests and alpha level 0.05 will be used. Confidence interval (CI) will be calculated. For all computations IBM® SPSS® statistical software will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Consecutive patients, aged between 18 to 30 years, with diagnosed maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspects from normal occlusion
Key inclusion criteria (2 listed)
- Maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspect from normal occlusion measured as interincisal distance
- Age between 18 to 30 years
Key exclusion criteria (4 listed)
- Systemic diseases in the musculoskeletal apparatus
- Drug abuse
- Poor psychic status
- Disease in the temporomandibular joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthognathic SurgerySurgical corrections of dentofacial deformities and malocclusions. | Procedure or surgery | – |
Primary outcome
Changes in upper airway volume
Time frame: Preoperative and 12 months postoperative follow up.
Measurements in three dimensional radiographs from pre- and postoperative recordings.
2 secondary outcomes
Correlation BMI and upper airway volume.
Time frame: Preoperative and 12 months postoperative follow up.
Direction of surgical movements
Time frame: Preoperative and 12 months postoperative follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 11204058Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Walsleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep. 2001 Feb 1;24(1):96-105. doi: 10.1093/sleep/24.1.96.
- Background: PubMed 31399294Moscarino S, Kotter F, Brandt M, Modabber A, Kniha K, Holzle F, Wolf M, Mohlhenrich SC. Influence of different surgical concepts for moderate skeletal class II and III treatment on the nasopharyngeal airway space. J Craniomaxillofac Surg. 2019 Oct;47(10):1489-1497. doi: 10.1016/j.jcms.2019.07.006. Epub 2019 Jul 18.
- Background: PubMed 20537778Kim JS, Kim JK, Hong SC, Cho JH. Pharyngeal airway changes after sagittal split ramus osteotomy of the mandible: a comparison between genders. J Oral Maxillofac Surg. 2010 Aug;68(8):1802-6. doi: 10.1016/j.joms.2009.11.010. Epub 2010 May 26.
- Background: PubMed 20197163Kim YJ, Hong JS, Hwang YI, Park YH. Three-dimensional analysis of pharyngeal airway in preadolescent children with different anteroposterior skeletal patterns. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):306.e1-11; discussion 306-7. doi: 10.1016/j.ajodo.2009.10.025.
- Background: PubMed 28800842Bengtsson M, Wall G, Greiff L, Rasmusson L. Treatment outcome in orthognathic surgery-A prospective randomized blinded case-controlled comparison of planning accuracy in computer-assisted two- and three-dimensional planning techniques (part II). J Craniomaxillofac Surg. 2017 Sep;45(9):1419-1424. doi: 10.1016/j.jcms.2017.07.001. Epub 2017 Jul 12.
- Background: PubMed 28318923Bengtsson M, Wall G, Miranda-Burgos P, Rasmusson L. Treatment outcome in orthognathic surgery - A prospective comparison of accuracy in computer assisted two and three-dimensional prediction techniques. J Craniomaxillofac Surg. 2018 Nov;46(11):1867-1874. doi: 10.1016/j.jcms.2017.01.035. Epub 2017 Feb 13.
- Derived from this study: PubMed 37858599Pellby D, Bengtsson M. Do Patients Detect Changes in Breathing After Orthognathic Surgery? J Oral Maxillofac Surg. 2024 Jan;82(1):36-46. doi: 10.1016/j.joms.2023.09.017. Epub 2023 Sep 27.
- Individual participant dataSharing planned: No
Related trials for OSA
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Bengtsson, DDS, PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA and Malocclusion, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in upper airway volume (time frame: Preoperative and 12 months postoperative follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060133, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.